Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Dos...
FDA Recall #D-0169-2024 — Class II — January 26, 2022
Product Description
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a subsidiary of Organon & Co., Jersey City, NJ 07302; Manufactured by: MSD International GmbH (Singapore Branch) Singapore 638030, Singapore. NDC: 78206-114-01
Reason for Recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling Firm
CARDINAL HEALTHCARE — Dublin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3 units
Distribution
Nationwide USA
Code Information
Batch U027458
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated